Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women (NCT00697463) | Clinical Trial Compass
CompletedPhase 2/3
Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women
United States22 participantsStarted 2008-08-20
Plain-language summary
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide \[PTH(1-34)\], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.
Who can participate
Age range20 Years – 48 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Premenopausal women of all races.
* Ages 20 to 48.
* Regular menses (at least 8 periods in the last 12 months).
* FSH \< 20 mIU/ml during the early follicular phase, to exclude women in the perimenopause.
* Fracture subjects: documented low trauma fracture(s) at age \>= 18 (e.g., fracture associated with a fall from a standing height or less).
* Low BMD subjects: DXA BMD T score less than or equal to 2.5 at the LS, total hip, femoral neck or distal radius, who have not had a fracture.
* Control subjects: DXA BMD T score greater than or equal to 1.0 at the LS, total hip, femoral neck and distal radius, who have not had a fracture.
* All subjects must use appropriate birth control methods to prevent pregnancy for the duration of teriparatide treatment.
Exclusion Criteria:
* Secondary Causes of Osteoporosis.
* Disorders of mineral metabolism: primary or secondary hyperparathyroidism (serum intact PTH \> 65 pg/ml), vitamin D deficiency (serum 25OHD \< 30 ng/ml), hypercalciuria (\>300 mg/g creatinine), Paget's disease, clinical osteomalacia, osteogenesis imperfecta (OI).
* Recent pregnancy or lactation (within past year).
* Prolonged amenorrhea (\> 6 months) during reproductive years (except during pregnancy or lactation).
* History of anorexia nervosa.
* Malignancy, except cured basal or squamous cell skin carcinoma.
* Endocrinopathy: hyperthyroidism (elevated serum thyroxine and/or suppressed TSH), untreated hypothyroidism, Cushing's syndrome, prolactin-…
What they're measuring
1
Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)